Z-2231-2026Class I

Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) ANESTHESIA TRAY...

Name: Z-2231-2026 Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) ANESTHESIA TRAY...
Creator: Medline Industries, LP
Published: 2026-04-10
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2026-04-10 / Open, Classified / root cause: design

FDA source

Medline Industries, LP began a recall of Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) ANESTHESIA TRAY, Medline SKU DYNJRA1355A; 2) SPINAL ANESTHESIA... on 2026-04-10. FDA classified it as Class I and gives the reason as "Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing data integrity concerns and...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2231-2026
Classification: Class I
Status: Open, Classified
Initiated: 2026-04-10
Posted: 2026-05-28
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) ANESTHESIA TRAY, Medline SKU DYNJRA1355A; 2) SPINAL ANESTHESIA TRAY, Medline SKU DYNJRA2151.
Product code: CAI Circuit, Breathing (W Connector, Adaptor, Y Piece)
Reason for recall: Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing data integrity concerns and reported efficacy complaints.
Root cause tag: design
FDA root cause: Component design/selection
Action: Medline Industries, LP issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 4/10/2026 via USPS first class mail and email. The notice explained the issue with the component and requested the following: - Identify and quarantine the affected item and lot numbers (kit). - Respond to notice via the portal: Website link: https://recalls.medline.com, Recall Reference #: R-26-065-FGX1, using the Recall Code provided. - Once the response is received, over-labels will be provided to be placed on the affected inventory with instructions to remove and discard the affected component. - Distributors or those who have further distributed the product are directed to notify those to whom the affected kits were distributed and include the customers quantities on your response form. Upon receipt of your submitted response form, you will receive over-labels to provide to your customers to affix to their affected product. For questions, contact the Recall Department at 866-359-1704 or [email protected].
Quantity in commerce: 1100 kits
Distribution: Worldwide - US Nationwide distribution in the US Territory of Virgin Islands and the countries of Bahamas, Panama, Barbados.
Product codes and lots: Medline SKU DYNJRA1355A: UDI/DI 10195327179830 each, FI case, Lot Numbers: 26CBA272; Medline SKU DYNJRA1355A: UDI/DI 10195327179830 each, FI case, Lot Numbers: 26ABS307; Medline SKU DYNJRA1355A: UDI/DI 10195327179830 each, FI case, Lot Numbers: 25HBE663; Medline SKU DYNJRA1355A: UDI/DI 10195327179830 each, FI case, Lot Numbers: 25FBA408; Medline SKU DYNJRA1355A: UDI/DI 10195327179830 each, FI case, Lot Numbers: 25CBG043; Medline SKU DYNJRA1355A: UDI/DI 10195327179830 each, FI case, Lot Numbers: 24FBT395; Medline SKU DYNJRA2151: UDI/DI 10195327365400 each, FI case, Lot Numbers: 24FBT396.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2231-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2231-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-06-03	2026-05-28
Z-2232-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-06-03	2026-05-28
Z-2233-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-06-03	2026-05-28
Z-2234-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-06-03	2026-05-28
Z-2235-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-06-03	2026-05-28
Z-2236-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-06-03	2026-05-28
Z-2237-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-06-03	2026-05-28

Product code CAI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)